Okay, now could you just move down?
Go ahead and move down.
Okay, move down a little more.
There you go.
Okay.
Now just make yourself comfortable, relax.
I'm going to leave now.
What's an orgasm like for you?
I'm going to say that it's like a blooming flower.
It comes from the roots and grows up
until it spreads beautiful aroma around the room.
It's like coming down from the highest
and the best rollercoaster ride.
I think it's different sound.
It's definitely a different sound.
It would be like "ahhh" with the rollercoaster
but with the orgasm it would be "ohhh. "
Is there something that comes to your mind
when you think about having an orgasm?
War.
That's what I think about is the war in my head.
I'd like to.
I hope I do.
What's wrong with me... I can't?
And so by the time I get through
having this conversation in my head,
I am not involved anymore in the now
and in the activity that's going on.
Why does it hurt you?
It's vey frustrating.
It's vey, vey frustrating to enjoy sex
and to never get to have that release.
I don't want to be hurt anymore about this.
In this morning's "Healthy Woman" something new to deal with.
An astonishing statistic.
Forty-three percent of women aged 18 to 59
have some kind of sexual dysfunction.
Female Sexual Dysfunction.
Symptoms include lack of desire,
lack of pleasure, painful intercourse.
This is a vey new field of medicine
but there's a good chance the problem can be tackled.
The FDA has only approved Viagra for men
but some doctors such as Jennifer Berman
believe Viagra might help women too.
As many woman hold their breath and wait
for the cream or spray or pill that might work for them,
the race is on to be first.
The prize: Undoubtedly billions upon billions of dollars.
Vivus was a pharmaceutical company that was busy developing
an Of9aSM CfeaM for women.
Your name?
My name is Liz Canner.
Okay, iust a moment.
I'm a documentay filmmaker and Vivus contacted me
because they needed some help
with the clinical trial of their new drug.
Vivus is a company that develops drugs
for male erectile dysfunction
and we're currently getting into
the female sexual dysfunction arena.
We're doing some early phase clinical trials.
What we want people to do
is they're going have to come into a doctor's office
and they're going to have to apply this drug
and then we are going to have to measure a sexual response.
What we intend on using is visual sexual stimulation
which is visually explicit material.
Well, we need some help with the actual production of the video.
Vivus wanted me to put together erotic video
for use during the testing of their new drug.
I thought, "How could I take this job?"
How could I not take this job?
I was curious about the latest
scientific thinking about women and pleasure.
So, I gained permission to film Vivus for my own documentay.
Little did I know that I would spend nine years
documenting the medical industy's attempt
to change our understanding of the meaning of health,
illness, desire, and that ultimate moment: Orgasm.
What's the name of the company mean?
It's Latin for "alive" and I just had the feeling
that our obiective was to put life back into dead penises.
Twelve years ago today, I incorporated the company.
And as you can see it's a real joyous, boisterous crowd.
Vivus 12th Anniversay April 16, Celebrating 12 Years of Sexcess.
Why did you found Vivus?
After a radical prostatectomy for cancer
my privy organ was no longer alive.
And that's when I focused on what could be done
in the field of sexual dysfunction.
All the drugs that we developed, all of them started on me.
In 1996, Vivus was one of the first companies
to win FDA approval for a drug to treat Erectile Dysfunction.
It was on the market 14 months before Viagra.
It was heady days though.
You really... you watched the stock price go up evey day.
Our market capitalization was over $1.5 billion.
But for only a few days.
Then Viagra was launched, obviously,
14 months later and our sales of the product
actually started to deteriorate.
When Vivus was no longer the market place champion for men,
they started testing their erection drug on women.
This new treatment was called Alista.
How does Alista work?
What happens when you add Alista,
our product, with sexual stimulation,
what affect does it have on cyclic A and P?
In this case it increases it pretty dramatically.
That, in turn, decreases intercellular calcium,
which in turn causes increased blood flow.
How will you know if a woman has been cured by Alista?
The endpoint in the male is rather straightforward,
an erection occurs or it doesn't.
The female doesn't have that same type of a vertical indicator.
So we're dependent upon a diay or on questionnaires
rather than doing a measurement
of the amount of engorgement of the penis.
What about orgasm?
Well, an interesting equation here that increased blood flow
hasn't conclusively been shown to cause orgasm.
How many drug companies do you think there are
out there right now developing drugs for FSD?
There's probably at least 12,
developing all different types of things.
We're all in a race to see who can be first to market.
The top four contenders for FDA approval are approaching the start.
My work with Vivus began with a meeting with Kim Airs.
Vivus hired her to curate the erotic footage for the clinical trial videos.
Oh, hi Liz.
How are you?
She was a nationally recognized expert
on women's taste in pornography.
Well, I think when we're going to select videos
that I'm assuming that woman are going to enjoy watching,
I've really found that women do go for plot.
They do go for videos that are well-shot.
People go "porno, plot?"
It's really kind of funny.
Porno is so subiective.
It's like, what gets me off might not get you off.
Now, I'm a little worried about
if it's not the right porn for the majority of women
then this will have an effect on their result.
The only thing we can do is guess
because that's the whole tough thing about it.
If you're making something as standardized as a testing protocol
you have to assume that most women
are going to like what you give them.
That's why I don't want to have "Babes Ballin' Boys"
or "Butt Man's European Vacation. "
Oh look they're wearing condoms.
That's good.
So this, I mean this is definitely, this could...
Ohhh!
That's... I know.
See, she's got a little birthmark there.
I can make the sound effect.
So, I don't know which ones were tape 1 and tape 2.
Isn't it strange the way Female Sexual Dysfunction
was only recently discovered?
Right, to medicalize stuff that's been around since histoy.
You know, what is Female Sexual Dysfunction?
Is it you're withholding sex
because you know your husband's cheating on ya?
Is it wants and desires that are unfulfilled?
I mean, it's so complex.
The erotic videos would soon be screening
in exam rooms across America.
It was time to visit my doctor, Susan Bennett.
She teaches a class on human sexuality at Harvard Medical School.
I usually visit her when I need a checkup.
Is eveything okay with sex?
It's okay.
Today, I was checking up on Female Sexual Dysfunction.
Were there any new medical discoveries
that could have prompted this newly named disorder,
Female Sexual Dysfunction?
No new medical discoveries regarding women's sexual problems
that I know have been reported in literature.
We as a society think that we should be able
to fix eveything by just taking a pill.
If women think that they should be having an orgasm
evey time they have intercourse,
a lot of women are going to think
there's something wrong with them.
If women think that they should be
as libidinous at 60 as they were at 25
a lot of women are going to think
that they need medication to feel better.
But if in fact we say, "This is normal.
This is a normal part of aging.
You can still enioy sex. "
It's not a disease.
And you don't need a pill to fix it.
How did Female Sexual Dysfunction come to be seen as a disease?
How did that happen?
We don't know.
How did you're company ever start working on a drug for FSD.
What's sort of the stoy about how that came about?
I don't want to go there.
So is there anything organically wrong
with these women that you can find,
that you can locate, that Alista will address?
Well, that's not, uh... I can't answer that question.
How we ended up developing a drug for FSD...
We'll wait for the sun to go away.
Saved by the sun.
I don't know that I can say that.
A little bit after the time that Viagra had been launched,
one of the local N stations
had come to Vivus and were interviewing people.
In the foreplay process you apply
a small amount of cream in the vaginal area
topically to the sex organs...
One of the things that Lee said during an interview is,
"We're developing drugs not only for male erectile dysfunction;
we also have drugs in development for female sexual dysfunction. "
The cream would be available by prescription only
to women who are sexually dysfunctional.
But somehow that got picked up as,
"We've got drugs for Female Sexual Dysfunction. "
The market went wild.
We didn't even know what the disease was.
We just knew that we had something that treated erectile dysfunction
and could probably be used in females as well.
That's why we're in FSD.
Let me attempt to lay out what I see as one of the freshest,
clearest examples of the corporate sponsored
creation of disease, Female Sexual Dysfunction.
The key meetings... through the mid-to-late 90s and onwards...
the key medical and scientific meetings
where this new condition called Female Sexual Dysfunction
was being debated and defined and refined,
all of them were sponsored by the drug industy.
Who defines whether or not FSD is a disease?
Why is it now a disease where maybe it wasn't before?
That's a really interesting aspect to what it is that we do.
In order for us to develop drugs,
we need to better and more clearly
define what the disease is.
We, the drug company, define the disease.
We've been able to get thought leaders
involved in Female Sexual Dysfunction
and really work closely with them
to develop this disease entity.
Why on earth would we want a drug company
involved in developing or defining a disease?
Clearly they have a vested interest
inmaximizing thenumbersofpeople
they target with their drugs,
so they'll define the disease as big
and broad and wide as possible.
There's been estimates on the average
of 40 million women in the United States alone
may be affected by psychological disorders...
Sory, no, sexual disorders, Female Sexual Dysfunction.
If they can transform vey common female sexual difficulties
into Female Sexual Dysfunction and treat it with a pill
then that's a bonanza for their shareholders.
We at one point in this company we had five secretaries
that had a net worth of well over a million dollars in paper
in the stock of the company.
But Jane was one of the smart ones.
Jane was able to sell her shares for well over a million dollars
and so she retired at an age of 34.
So, those things happen when you're on a roll going up.
Well, it's a vey positive year.
Health costs are already exploding in the United States
and generally across the western world.
One of the biggest increasing costs
is coming from pharmaceuticals
and there is a whole line of argument that says
we are medicalizing more and more ordinay life.
Certainly in the last 15 to 20 years,
drug companies and the thought leaders that they're close to,
have been involved in some way in defining
and redefining and designing conditions.
Expanding old ones, creating new ones.
Because there's a lot of money to be made
telling healthy people they're sick.
One of the reasons the pharmaceutical industy
was involved with developing diseases
was that in order to create a prescription drug or treatment,
the FDA requires that it treats an actual disorder.
So when the FDA said yes...
Yes.
...Female Sexual Dysfunction is a legitimate disorder;
it started a gold rush as inventors searched for cures.
We're going to call the device the Orgasmatron.
Essentially what is done is an electrode
is threaded up the spinal cord.
And then by adiusting the electrical parameters
you will have an orgasm.
Leaving it on at a low level
you would have a pleasurable sensation there
for as long as you wanted.
All day, waiting in traffic, shopping,
all the sort of boring chores of eveyday life.
Yes.
The potential market includes the one third of women
over the age of 25 in the United States
who have problems with orgasmic dysfunction
so I could see having clinics in major metropolitan areas
and other areas overseas would be Amsterdam, Berlin, and Sydney.
I hope to make money off this.
And what do you want to call your clinics?
Well, I'd thought of a vey simple sign
that says, "Orgasmatron, Inquire Within. "
This is a symbol of marital happiness.
And so we have the two ducks kissing each other.
They're salt and pepper shakers.
Like I said, people give me things
and I stick them up there and they know I like this stuff.
This is Randle, my husband, and this is me.
We're two old goats, you see.
I am in a loving relationship and my husband
has unconditionally accepted me where I am
because he does know this not about him, this is about me.
All of my life I have had difficulty achieving orgasm.
This box will actually accommodate a total of eight electrodes.
Charletta and ten other women were enrolled
in a clinical trial of the Orgasmatron.
Basically, you have the ability to adjust the sensation
no matter what position you're in.
So, I'm going to turn it up again...
It's taken me a long time to get to the place
where I wasn't humiliated so that
I could come here and do this and even talk to you like this.
So I'm really excited about it.
I feel like I'm well on my way to being healed
and being more healthy and normal.
Female Sexual Dysfunction, per se, probably runs 80... 83 percent.
Orgasmic Dysfunction is a subset of that.
I think that's vey interesting
and I think there is a tremendous need then
to do this for women, to help women.
I'm not from the South but I got here as quick as I could
and one of the sayings they have around here is that,
"If momma ain't happy, nobody's happy. "
That's right.
Each time you use the device,
and if it does work, we'd like you to fill this out too
please grade your orgasmic experience.
If you need more pages give me a call,
and I'll get some to you.
Okay!
We have high hopes here, huh?!
Yes ma'am.
Yes we do.
I'm in this to heal myself.
Not only am I not normal, I'm diseased.
That feels real bad.
Coming from the religious background I came from
there was a lot of mixed messages about do and don't
and this is wrong and that's right.
Well, the flesh was evil.
The flesh was wicked.
And so you didn't want to indulge yourself in the flesh,
or g ive over to the flesh.
They typically can be accomplished within about 20 minutes time.
And how long did this one take?
About 40?
About 40 minutes.
A new article in the British Medical Journal by Ray Moynihan,
launched a debate about whether
Female Sexual Dysfunction was an actual disease.
So, what got you writing this stoy?
A friend of mine sent me a press release
that she'd got from a company called Vivus.
"Alista: New Hope for Sexual Healing for Women"
and it's from the Investor Relations Group.
Is this about money or medicine?
There's talk here of 430/o of women suffering from this dysfunction
and that really, you know, that triggered alarm bells.
It is a secret epidemic... 430/o of American women
experience some kind of sexual dysfunction.
430/o of women suffer from
what is now called Female Sexual Dysfunction.
Here's the actual paper that was
in the Journal of the American Medical Association
that first launched this 430/o figure on the world.
It's based on a survey from the early '90s.
Women were asked a series of questions
about common sexual difficulties that they might experience.
If they answered "yes" to any of these problems,
they were put into a box that said Female Sexual Dysfunction
and that's how you get to the 430/o figure.
Ed Laumann, the sociologist from Chicago who did this survey,
he himself says that a lot of these 430/o of women
are "perfectly normal," that's his words,
and that "a lot of their problems arise
out of perfectly reasonable responses
of the human organism to challenges and stress. "
A correction appears in a subsequent issue of the Journal
disclosing that those authors had financial ties to Pfizer.
The pharmaceutical industy, through a whole range
of vey sophisticated PR and marketing strategies
is actually changing how we all think about
our bodies, about our health, and about our diseases.
Essentially you're turning healthy people into patients.
How does one effectively protest against the existence of a disease?
New York University professor of Psychiaty Leonore Tiefer
was tying to figure that out... fast.
I'm going after the pharmaceutical industy
because I iust got really upset with the hunt for the pink Viagra
and I thought, well, over my dead body,
and, I'm iust going to do something about this.
We know the truth, there isn't a pill for eveything.
What I'm concerned about is that there is a shift going on
in the meaning of sexuality in the culture
towards this commodified, individualized thing
that has a normal level,
and that if you don't experience it in that way
there is something wrong with you
and you need medical help.
I just want to say it ain't so simple.
It's different for different people.
I like the idea that desire is a co-created phenomenon
rather than it being an internal thing.
It's kind of like friendship.
You don't walk around, how many times in the last month
did you have the friendship feeling?
You know, friendship is something that happens between people
and I think sex is something that happens between people.
Leonore Tiefer runs the New View Campaign,
with its hundreds of members,
from her small apartment in Manhattan.
How is your campaign going to stop
the FDA from approving a drug for FSD?
The FDA hearing, the public is going to hear from us,
hopefully, as well as from others,
that you need to prove that there is a disorder
and you need to prove that your drug is safe
and you need to prove that your drug is effective.
And we're going to go down there
and ty to throw a roadblock in front of their steamroller.
What's wrong with drug that helps women achieve a better sex life?
It's not iust the drug.
It's the drug in the context of the advertising,
of the lack of education, of the lack of regulation.
I think that it's a manufactured term to create a market for drugs.
While Leonore used the airwaves to spread her message,
medical experts pushed the concept of Female Sexual Dysfunction.
Actually there are more sexual dysfunctions in women
than there are in men.
This is Viagra, this is actually a sample pack, but these... tada!
Most of the medical experts had financial ties
to the pharmaceutical industy but did not disclose them.
Viagra is useful in a smaller subsection of women
but it can improve blood flow and lubrication
to women who have that as a problem.
Now there was a movement.
Our proposed indication, as you've heard,
is for the treatment of Hypoactive Sexual Desire Disorder.
And a counter movement.
Assessing sexual experience is subtle and complex.
Evey study must be closely examined for what they leave out.
The two sides were really duking it out.
And it remained to be seen who would define
woman's sexuality in the 21 st centuy.
Ladies and Gentlemen, we'd like to welcome you to Salt Lake City.
The local time here is 11:06.
In the midst of the battle,
Vivus arranged a luxurious ski trip in Utah
for the doctors who ran their clinical trials.
There they planned to announce
the long-awaited results of the clinical trial of Alista.
The same one that featured the erotic videos that I edited.
You know, they come and they relax.
They get an opportunity to do some skiing.
The one good thing, though that you do establish
at a meeting like this, is you establish the relationships.
And so once you have the relationships in place,
you can play on those.
Come on, sing with me now.
The words, the words!
There just are no words for how good this drug will be
...once it becomes on the market!
The best.
These are the people that make it happen.
Yay!
I get up at 6:30 evey morning and I work until 9:OO evey night
all for the bettering of Female Sexual Dysfunction.
We gotta go.
It's time.
It's show time.
At the last minute a senior executive
banned my camera from the meeting.
I managed to attend anyway and discovered that Alista
was not doing nearly as well as they'd hoped.
It was interesting what we found in this study
was that even when you gave patients placebo,
when you showed them visual stimulation
So you basically discovered women like porn.
Yeah, so, so porn works.
Porn works.
It's not, you know, the panacea for solving all your sexual troubles
but it does elicit sexual responses.
Despite the high success rate with the placebo
and the plain fact that porn works,
Vivus decided to continue their clinical trials of Alista.
You can ask questions of patients
that are vey simple questions on the surface of things,
but small changes in how you ask a question,
can lead to sometimes vey significant changes
in the answers that you get to a question.
It's just that improvement is different than enhancement.
And, and there is a little difference.
We knew there might be some sort of a small difference
but that looks like a big difference.
The data never lies.
Back in North Carolina, Dr. Meloy was wrapping up
the clinical trial of the Orgasmatron.
I'm waiting for my second visit with Dr. Meloy.
It's not working for me vey well
and if you want to come closer,
I'll demonstrate for you.
It's working in this leg watch.
I said I'm not much good unless you like to be kicked in the behind.
I had a feeling they were going to take it out today.
Were you able to get close?
Uh-uh.
Not even.
And I tried evey position you can imagine on that.
I'm disappointed.
In your clinical trial how many women
did the Orgasmatron work on?
We've, ah, succeeded in stimulating eight out of nine,
but we've not been able to maintain the electrode in but six,
and of those six it's worked in four.
We're able to stimulate 91 O/o of the women, 1 O out of 11.
But at this point I just give up.
I mean it's okay.
I accept myself the way I am.
There are lots of ways to achieve orgasm
other than just to have sexual intercourse.
And...
Can I just ask you a question?
Can you achieve orgasm through other means?
Yes, I can.
So I'm not without orgasms.
I can have orgasms but it's just not the normal situation
where two people get together
and they have sexual intercourse and each has an orgasm.
And that's what I say, maybe that's not real.
Maybe that's just what the movies tell us is real.
Exactly.
Most women would not have orgasms
from the kind of sex you see in the movies.
Seventy percent of us need
direct clitoral stimulation in order to climax.
So that's what you were hoping,
that this device would allow you to have orgasms during sex?
Yes, during sexual intercourse,
and just, again, in what I think is a normal way.
But you have absolutely washed that out of my mind.
I no longer know what's normal.
So that's wonderful because that's a brand new start.
Charletta was enrolled in a clinical trial
for women with FSD despite the fact that she was healthy.
To heck with that disease stuff.
How many women risk being taken advantage of
because of a lack of comprehensive sex education?
What about sex education in America?
Seems to me there's an interesting double standard there.
Vey soon we'll see some sort of orgasm pill
or orgasm nasal spray and we're teaching people
abstinence only in our schools.
Did any of you get abstinence only sex ed training?
You did.
Well, it was... the woman who was teaching the class
first of all divided the guys up in one room
and the girls in the other.
She was about 80 years old, vey, vey traditional and was like,
"Sex is bad so don't have it until you're married".
Our health teacher evey time she told us about
another form of contraception or STD prevention,
she would just say, "Well, you don't need to know this
because you're not having sex till you're married,
and then when you are married
you're not allowed to use birth control anyway.
Because if you use contraception
while you're married, you'll go to hell. "
Do you think that affected you at all?
Oh no, not at all.
I...
I was going to college and my godfather
had a talk with me saying, you know,
"Wait until you finish college, after college,
then go ahead and have sex. "
But my same godfather had a conversation with my brother
and said, "Have as much sex as you can possibly in college. "
So what would you all say has been
your primay source for sex education or information?
Peers.
Peers?
So your peers have shaped you the most
and given you the most information?
Yeah.
Women come into Good Vibrations, now, not just young women,
older women, women the age of their mothers,
women the age of their grandmothers,
and they're not sure where their clitoris is.
How are those women, who can't find the parts of their body
that might help them feel the best,
supposed to function sexually?
Is a drug going to help them?
Maybe if has a map of the clitoris on the box.
I hope nobody steals my idea.
I'm Dr. Carol Queen, and I'm the curator of the vibrators.
One of the reason I love these antique vibrators
is because my first vibrator was an antique vibrator,
a Stimulax Junior, vey much like this one.
And I read in a women's magazine in about 1973 about vibrators,
and thought, isn't that what
my parents have in the hall closet?
I ran down.
I dug it out and then I snuck it back up to my room.
I turned it on.
It was my vey first orgasm.
After that I was not going to put the thing back
and sory to say that my parents
never asked me for it back.
So clearly, I was getting a lot more out of it than they ever did.
The reason we have vibrators today
is because over a hundred years ago,
in the late 19th centuy, doctors were using vibrators
to treat a disease in women called hysteria.
When a woman who had hysterical symptoms
would go and see her doctor,
and her doctor would apply vibration,
and she would have a hysterical paroysm of relief,
something that today we would call an orgasm.
And by the end of the 19th centuy,
some sources estimated that three quarters
of women suffered from hysteria.
Those of them who could afford to do so
went to their doctors on a weekly,
sometimes more frequent basis,
and it was a big business.
We no longer call hysteria a disease at all
and what it probably was was a combination of stress,
and women's hard work plus sexual deprivation
and inability to get all the way through sexual response cycle.
In a lot of ways, female sexual dysfunction
is the hysteria of this centuy.
It's a new way of putting a lens on women's sexual experience
from a distinctly medical perspective.
Woman need to feel entitled to their sexual response.
They need to go to their doctors and demand to be heard,
and demand treatment, because it is available.
Urologist Jennifer Berman and sex therapist Laura Berman
were the first to really brand the condition of FSD.
They have become the pseudo celebrities
associated with this particular dysfunction.
In 2001, they wrote the first popular book on FSD
and used it to launch a huge marketing campaign.
This is a device that was developed
to enhance genital blood flow.
What Viagra does is it increases the blood flow to the genital area.
You crave sex.
You can't stand sex.
Within a vey short time, they had their own N shows...
...a call in radio program,
a syndicated newspaper column and sex clinics.
From the Berman Center in downtown Chicago,
it's time to talk about your love life.
The Dr. Laura Berman show... no men allowed!
This is all about women.
Hi, welcome to the Berman Center.
My name's Neyla and I'm the patient concierge.
I just wanted to introduce myself.
If you want to follow me...
...you'll meet with the sex therapist.
The sex therapist will be looking to determine
if there is any emotional or relationship issues
that may be contributing
to the patient's problem for coming in today.
Do you want me to talk to you or talk to the camera?
Talk to the camera.
The Berman Center is really sort of a culmination
of my professional dreams over the past 1 O to 15 years
I've been working in this field.
Well, my husband, he's the one
who raised the money to open the Center
but also he wears a business hat,
in a way that I as a clinician don't,
so it's really a nice marriage literally and professionally.
If vibrators were recommended,
if lubricants were recommended,
it would be at the patient concierge point
that we would go through them, and talk about them,
and answer any questions that they had.
So you were really involved
at the beginning of this weren't you?
Mm-hm.
How did it all happen?
Yeah, from the beginning, when all of the focus started
on female sexual dysfunction, the medical piece of it,
there have been a lot of companies
that have been tying to develop drugs
or medications or medical devices for sexual dysfunction,
and I've been involved with just about all of them.
I was one of the principal investigators of Viagra in women.
At the halfway mark, Viagra, the favorite, is bringing up the rear.
There's trouble on the track.
Viagra is not working any better in clinical trials than sugar pills
so Pfizer yanks her from the competition.
So would you recommend that doctors continue
to prescribe Viagra for women?
I still feel really strongly that Viagra and drugs like it,
the vasodilators in general which improve blood flow
to the genital area, definitely have a role
as part of a comprehensive treatment plan for women.
The initial...
Laura Berman is playing a dangerous game here.
She's promoting the use of Viagra even after Pfizer
has found it does not work in women
and the health risks are unknown.
Once a drug has been FDA approved for a particular condition,
doctors can legally prescribe it for any disease.
It's called off label use.
That said, it's illegal for pharmaceutical companies
to promote off label use of their drugs.
So would you recommend that doctors continue
to prescribe Viagra for women off label?
I do recommend it for women
who have arousal problems, loss of sensation...
Here is a senior figure, Dr. Berman, suggesting that doctors
prescribe Viagra off label and yet Pfizer has called off
the trials for Viagra in women.
They can't show that Viagra has a meaningful benefit over sugar pills.
It's a vey subtle way to get around the approval process.
The Berman sisters are key characters in the development
of female sexual dysfunction.
The trouble is that with such influential figures,
they are so close to the pharmaceutical industy,
on occasions working directly with drug companies,
paid by drug companies.
And our topic is Viagra.
It does a bing for men.
It does sort of the same thing for women.
Our patient takes Viagra.
Viagra.
And I have no vested interested in, in Viagra.
Our goal is to, whatever drug, whatever hormone,
is to help women, but...
Does Viagra work?
Viagra works.
Now you'll be going to the Sensoy Testing Room
where the physician will monitor blood flow to the genitals.
If you'd like to go ahead and have a seat,
she'll be with you shortly.
This piece of equipment is going to test your nerve function
at your clitoris and right inside the vaginal opening,
to warmth, coolness, and vibration.
And how that's done is I'm going to give you this button.
Here's the first probe that we are going to use
and the metal tip on this is going to be placed against your clitoris.
So would you hand that to me or would you hold it?
No.
At $50,OOO I don't want anyone to drop it.
It'd be an awfully expensive visit.
Okay.
Um, then you're going to depress your button
to indicate to me that you have felt something.
Okay?
Are there articles that I could read about the tests that you run
in terms of what the norms are?
Medock, the name of the manufacturer for this piece of equipment,
Medock has the information that determines the normal ranges
that we look for in these patients.
You'll wear these 3D glasses.
You'll be watching an erotic video
and the whole idea again, is to get yourself excited.
Bring some blood flow to your genital area.
Your total today is $1,500.
We take cash, check, or charge.
Television in the United States wasn't always full of doctors
and ads pushing pharmaceuticals and diseases.
If you just say no to drugs,
you'll be saying yes to a whole lot more.
While Nancy Reagan was telling us to just "say no to drugs,"
her husband was signing a bill that would make us
the pill-popping nation that we are today.
President Ronald Reagan opened the floodgates
for direct to consumer advertising of pharmaceuticals.
In 1997, thanks to further deregulation
the pharmaceutical industy started advertising like crazy on N.
This is the age of Fosamax.
Oh no!
I live deep under your nails.
They aren't kidding.
And I've been on it for years.
And ya gotta love that!
Even our pop culture heroes are dependent on prescription drugs.
Well son, your uncle Homer is like 800/o of America,
whacked out on prescription drugs.
But users are losers.
You're confusing drugs with DRUUUGS.
For now, the United States and New Zealand
are the only countries in the world that allow
direct-to-consumer advertising of pharmaceuticals.
But the drug industy is putting pressure
on other nations to change their laws.
What we do is we prescribe.
That's what we do as a profession.
We're not paid for counseling.
We're paid for action, writing prescriptions,
seeing a certain volume of people per unit time.
I think doctors want a pill too.
Doctors want to be able to write a prescription
for something that is going to help a woman
feel better about her sex life.
It's the easiest part of what we do
and is kind of what patients have come to expect.
Deep into the race the key players are quickening their stride.
But wait!
From out of nowhere, over on the sidelines,
comes what could be a real game changer.
Sex surgey.
Ow!
Some of the new inventions to treat FSD
were starting to hit the marketplace.
At a trade show for doctors,
medical companies were marketing new extreme treatments.
It's a bloodless surgey.
I'm here to speak to physicians that are interested
in incorporating a new procedure into their practice.
It's a procedure that gives women additional choices
for regaining sexual gratification that they maybe have lost
as they've aged or had children.
You use the laser to make an incision,
you're able to push the bladder back up
to where normally in a young person it would be
and then bring the muscles back together making it tighter.
Do you think there's a chance
that some of the nerves of the clitoris could get cut?
Well with any surgey there are going to be risks.
We also train them to do something that's called
Designer Laser Vaginoplasty.
A lot of women feel like they're unhappy
that their labia are abnormally long.
And it really is in a sense plastic surgey.
What is an abnormally long labia?
I think that's up to the women to decide, and, so again,
this is all about giving women choices.
You're feeling uncomfortable about this?
I am, I'm hating this part of it.
You are?
Yes.
Why?
Hmmm.
See now I might have to ask for the tape back.
Yeah, you don't want to talk about this?
No, just because this part of it, I am ambivalent about.
The plastic surgey part?
Mhmm.
I think that our culture has made women feel vey self conscious,
and uncomfortable with who they really are
and so there's always this attitude
of feeling like they need to be perfect
and really I think people should be happy with who they are.
These magazines have published articles
promoting cosmetic genital surgey.
One of the things that really motivates gynecologists
to start offering these procedures
is they went into gynecology to deliver babies,
to help women, all of those good things,
but after a while they find that they're tired of being on call,
tired of running out and delivering babies in the middle of the night.
And it just gives the surgeon or gynecologist
a better quality of life for himself or herself.
I asked Lisa to show me before and after photos of women
who had undergone the surgey.
I would be more comfortable if you wouldn't film the pictures.
So this is actually the presentation as part of the training course.
See you asked for it.
Oh.
Okay.
I think I'm going to be faint.
They want to look like little girls.
This is all making them look just like little girls.
I hadn't thought of it in those terms, but you're right.
That's really disturbing.
So, yes, at least give me enough time
to find a new job before you air this.
You're going to go job hunting now?
I am.
I'm going to go home and go job hunting
so I don't have to feel conflicted any more.
I don't blame you.
Yeah.
The procedures that I had done were a labial reduction and a...
...I don't know how to phrase it,
I, I, guess it would be a clitoral hood reduction as well.
I did think that this would help me achieve orgasm with sex
and my gynecologist did have hopes that it would help.
The surgey itself went well.
When I got home I actually got a mirror to look at the surgical site
and there was a huge gush and a huge splurt of, of blood.
And then at that point I knew a suture had popped.
By the time I got to the emergency room
it was dripping down my leg onto the emergency room floor.
They had to do emergency surgey.
The tissue in the genital area is vey vascular.
If it does bleed, it's gonna bleed a lot and fast.
My doctor said that I lost about a third of my blood volume.
And had I not sought emergency treatment
as quickly as I did it could have gotten a lot worse.
And, yes, there was the possibility of me dying.
I was hoping that after this procedure I would be able to achieve orgasm
with just intercourse but that did not happen.
Due to intense marketing, eight cosmetic genital surgey clinics
opened up in New York City.
More research, less marketing.
Say no to designer vaginas.
No two alike, all are beautiful.
Teenagers are having this done.
And there's the sense that the labia minora
needs to be sort of symmetric and tidy.
Labia minora are a vey important part of erotic genital tissue.
Eveybody's different.
Some people have vey small labia,
some people have asymmetric labias,
some women have vey long labia.
It's all normal.
Any kind of cosmetic surgey to the external genitalia
is a form of genital mutilation.
I can't think of any rational reason for it.
One of the main reasons not to do it
is that women can end up with chronic pain syndromes.
And it, we shouldn't be allowing it and we are in fact allowing it.
It's eight years into the race and it shows.
Uh-oh.
Vivus can't get Alista work any better than a placebo.
So that cream is out of the race.
With Alista and Viagra dropping out of the race,
it was becoming clear that the drugs
that have been made to give men erections,
were not working On WOMen.
It seems that it takes more than increased vaginal blood flow
to give women orgasms.
Hi, Craig.
This is Liz Canner calling.
I'm calling just to check in with you
about the filming that we discussed.
Still tying to reach you because I wanted
to check in with you about filming.
Still tying to reach you.
Perhaps because they were failing,
Vivus did not want to be interviewed anymore about Alista.
The creams, pills, and vaginal surgeries, and the Orgasmatron
were not providing the quick fix
that the industy had been hoping for.
Maybe, this is because most of women's sexual problems
are not purely physiological.
I was working full time and taking care of the kids
and taking care of the house, taking care of eveything.
I was physically tired, I was mentally tired,
and I was emotionally tired.
The last thing that I wanted at night or any time
was for someone to touch me
in a sexual manner because it was just,
I felt like all day long I had been pulled at and touched
and I had little hands On Me.
You know, taking care of kids all day and then still tying to work.
Sex was just not important.
I was abused sexually as a child by a relative of mine.
I do realize that men of my culture specifically,
that I have a much more fearful reaction towards physically.
I've had experiences where I've felt like um,
my whole body sort of closing off to a certain type of person
and I'm sure that has to do with the past.
My first few years of sexual experience were not that enjoyable.
It was as though I felt the urge to,
but I couldn't let go into enjoying it.
I had an idea of what sey was and I wasn't it.
Can't even really lose myself in the moment 'cause I'd be like oh,
well, I have to, you know, be, you know,
don't look at me from that angle kind of thing.
Ya know, not in the middle of the day when all the lights are on.
I'm, you know, I'm not in that relationship.
I'm in another relationship but I still have kids,
and I still work full time, and I still have a life,
and it's still busy and it's still crazy
and it's still hectic but it's different.
And now the workload around the house has been lessened
because there's more equal sharing.
I'm not as exhausted as I once was
so intimate and emotional needs are being met
and so I do feel like a sexual being and I do want sex.
I do desire it.
My partner right now who's like one of the most caring, sensitive people
in the world, is of the same culture as me.
And when we initially started seeing each other,
I was vey, vey, vey, vey afraid.
Memories don't go anywhere.
They just physically stay with you.
I see a therapist.
I think it's something that's really, really important to realize
that most sexual health problems are all, a lot related to things
that therapists or psychiatrists needs to talk to you about.
So I definitely feel that things have changed,
but I mean I'm getting there.
I wouldn't say that I'm like, I've reached full sexual liberation.
But I really learned how to love myself
and give myself what I needed
and to be able to make myself feel beautiful and sey
or not even make myself feel that way
but just allow myself to feel that way.
Maybe I feel that way naturally
if I'm not tying to judge it or confine it.
Okay.
I'm gonna leave now.
Attractiveness, actually, is like a feeling that comes from within,
not how good your thighs look in fluorescent lighting.
Dude.
The whole thing with taking drugs for this or for that,
my belief is living for a drug free America.
I mean, don't take drugs.
Sex expert Kim Airs invited me to meet up with her
at a pharmaceutical sponsored conference on FSD for doctors.
Kim was planning to train doctors in her non-medical,
pleasure-based approach to helping women with sexual problems.
But the organizers would not allow Kim to speak.
So she crashed the conference
and booked her own room in the same hotel.
I'm completely thrilled by the turnout
and I'm so honored to be able to do this today.
I don't have a clinical background.
I have a pretty active sex life and always have.
And I combined two of my favorite loves
with my career which is sex and retail.
I tend to use things to teach women about their own anatomy.
And fortunately, there are some great tools out there.
This is one that you may or may not have seen.
It's called the wondrous vulva puppet.
Now, it's pretty accurate as I like to point out,
except for the fact that it's satin and velvet.
So something like this is just really unobtrusive,
not scay and kind of nice and comfy.
I've done a lot of workshops that women have like held this
and have actually cried because it's so intimate to them.
Now, getting into the realm of sex toys.
There's quite a few out there
but these pertaining more to FSD symptoms.
This is the coolest thing out there.
All right, pretty simple.
Now when you squeeze this, you squeeze it with Kegels.
And it'll make the...
Ooh, I love that.
Isn't this something!
You get the white lights going.
Bingo.
I tried this with a pal and it was so much fun.
He's like, "Go on, go on, get more lights, get more lights!"
I'm like hrrrrr, you know?
Yeah.
I think this was absolutely priceless.
It was wonderful, and, especially when we
have been exposed to so much scientific data.
This is the kind of meat and potatoes stuff we need.
And uh, maybe I shouldn't have said meat and potatoes.
I would hope that each year she can continue to do it.
And I don't know, maybe we can even begin to integrate it
into the program because this is incredibly important stuff.
So I really want to thank Kim.
Just when the world of sexual medicine
seemed like it was improving,
Procter & Gamble announced that they had a drug that worked.
Intrinsa shoots out in front.
She's picking up the pace.
Wow.
Look at her go!
It looks like she will be the first FSD drug to win FDA approval
and claim the billion dollar prize.
A new female sex patch called Intrinsa
is on the fast track to FDA approval.
It is said to significantly boost sexual desire in women.
There's an update in the news now about the search for a treatment
for sexual dysfunction in women.
Low doses of testosterone delivered through a skin patch.
Let's just say the next thing we're doing in this campaign
is that the FDA is going to evaluate the testosterone patch.
Now, I don't know if the FDA is expecting...
well, never mind the FDA.
I don't know if P&G is expecting a lot of opposition.
They are expecting me.
And I'll do the best I can
but it would be nice to have some other people.
And whatever happens, sex is acquiring a different meaning.
We have to be prepared.
Thank you.
Vivus was a pretty small company but Procter and Gamble sure wasn't.
Leonore and the New View Campaign were up against
one of the biggest companies in the world.
Procter & Gamble was so confident
that their drug was going to be approved
that they began a $1 OO million marketing campaign for Intrinsa,
months before the FDA Hearing.
Women getting the hormone, not a fake patch,
said they had four times more sex than usual and were happier.
These are highly statistically significant results.
Most women who have low libido
or even other kinds of sexual function complaints
may have low testosterone and don't realize it.
Procter and Gamble and a lot of these other companies
are banking on a simplistic notion
that sexual desire is just testosterone.
It's iust hormonal.
Most of the news stories on the patch failed to mention
some of the likely causes of a diminishing libido.
Why did P&G decide that they wanted to start looking at testosterone?
P&G has been vey committed to women's health.
And we have tried to take care of the full woman.
When they first became interested in the testosterone patch,
they felt that this would add to the whole gamut
of taking care of the whole woman.
So when you did your clinical trials,
who did you test the testosterone on?
The clinical trials were in women who've had surgey
and had their ovaries removed.
Were they also taking estrogen?
Yes.
In fact all the trials we've done so far, surgical and natural,
all the women have been on estrogen.
So it's not gonna necessarily be the miracle drug for eveybody?
Personally, I believe it's going to help most
because it does improve desire.
It does improve arousal.
It does improve orgasm.
Right now, in clinical practice,
there really is no normal for testosterone levels.
And when you actually ask somebody, well,
"If the level's high what will you do,
if the level's low what will you do?"
And people, physicians really can't say what is normal.
In order to learn more about testosterone,
I met up with behavioral neuroendocrinologist
Kim Wallen of Emoy University.
From a vey early age, I had this sense that sex
was something that was extremely powerful
and I also had this sense
that we didn't know vey much about it.
So when I discovered in college that you could actually study sex
that was really I think, what I was most interested in
and most committed to.
He has devoted his life to studying the effects
of hormones on sexuality.
It just turned out that I ended up working with monkeys
and I think they're actually an ideal system.
It's clear that hormones are probably not even the biggest factor
that influences sexual motivation.
Context is much more important.
If I see a young couple on their honeymoon in the Caribbean,
I actually don't need to know what the woman's hormone level is,
or what the man's hormone level is,
to know that they're likely to engage in sex.
And it really has nothing to do with hormones in that situation at all
because the social context of their relationship,
and the context of where they are in a relaxed atmosphere
may be actually much more important in influencing sexual behavior.
So why is this testosterone patch thought to work?
I think there are a couple of reasons why testosterone
is being pursued so actively by drug companies.
I think that there's this vey strong notion that testosterone
is a hormone that affects sex drive.
We certainly know that that's the case in men.
I think it's easy for people to sort of feel,
well, it must do the same thing in women.
It must affect sex drive also.
But we really still don't know exactly how these hormones
interact with each other to affect female sexual desire.
So what are they doing there?
So she's saying, "These are my genitals, don't they look good?"
She's going to actually start tying to turn this guy on.
So what do you think you've learned
over all these years about sex?
To pay more attention to females.
That was my first great insight,
was that females were actually telling males a lot
that males weren't paying any attention to.
You know, we need to talk a little bit about it
but I'm not sure what we're going to do about it,
is this FDA Meeting on December second.
You know, I've started collecting the original research on these tests.
These women are not being tested for a testosterone patch.
These women are being tested
for estrogen plus a testosterone patch
and nobody's talking about that.
And it is my belief that they tried without estrogen
and the patch didn't work.
It's, of course the question is what have they not included?
The success will not be measured by stopping this drug
because there are... Andrasorb and Alista,
and Estracin and Estratest,
and Avista, and Femprox, and Intrinsa,
and Liveal, and NM1870,
and Steronorestocine, and testosterone creams,
and Tostrel, a gel and...
Do you think that there's a chance you could have an effect?
Well I always think there's a chance we can have an effect.
I'd like to first remind the audience and committee members
to please put your cell phones on silent or vibrate.
The FDA hearing was set up like a debate.
Procter and Gamble presented their data.
Then the FDA reanalyzed that same data.
The public had a chance to weigh in as well.
The judges were a panel of expert doctors.
Finally, at the end of a ten hour day,
the panel voted on whether to recommend Intrinsa for approval.
This new drug will be requested by many people
on whom it has not been tested.
Believing that it's safe, these women may well become
the guinea pigs of the twenty-first centuy.
I would urge the committee to not approve this
because I think it is a premature drug that simply does not solve
what is a vey important and critical problem,
but this is not the answer.
The next presenter is Leonore Tiefer.
My name is Leonore Tiefer.
No money, no way.
As a psychologist with over 30 years of teaching, research,
awards and publications in sexuality,
I see today as a perilous moment
in the histoy of women's sexuality.
Intrinsa is not a glass of Chardonnay
and yet we have already seen
that it may well be promoted with a giggle and a wink
as the female Viagra.
Not so.
This is a steroid hormone women must continuously take
for weeks before getting an effect.
Patients treated with testosterone also experienced
significant increases in numbers of sexual episodes
and in numbers of orgasms.
The key issue for us, there was a strong placebo effect
that persisted throughout the trials.
And the difference of placebo compared to testosterone treatment
is not clear to the division.
It looks to me like about 360/o of the placebo patients
would really like to continue the therapy
and about 500/o of the treated patients
would really like to continue the therapy
and I want the sponsor to consider marketing the placebo.
The testosterone transdermal patch is both safe and efficacious.
There do not appear to be
any major hormone safety issues with Intrinsa.
Testosterone was vey strongly actually related to breast cancer risk,
2.2 fold increase risk of developing breast cancer.
This was highly significant.
In addition to being concerned about the side effects of testosterone,
the FDA was also alarmed by the health risks associated
with the long-term use of estrogen as found in the WHI study.
In reality there was a 240/o increase
in the risk of coronay heart disease.
There was a 31 O/o increase risk in stroke.
Venous Thromboembolism was doubled.
There was an increase in breast cancer.
There was a doubling in the rate of dementia
if one was assigned to active hormones.
Just because the WHI studies were disappointing,
we're not debating the safety of estrogen here.
It's only the patch.
I'm not so sure if we are or are not.
I don't understand this.
I mean you know, if they're mandating these patients
have to go on long term estrogen and then use the patch,
then basically aren't you back to where you are
with the discussion of the safety of estrogen?
You're putting a product on top of a base that already has warnings.
The risk that was seen with Vio_ was vey modest
but when you translated that to 105 million prescriptions
and 20 million Americans, it represented an enormous burden.
The potential for this agent to increase the risk
of cardio vascular morbidity and mortality is substantial.
I also don't want to expose several million American women
to the risk of heart attack and stroke
with their devastating consequences
in order to have one more sexual experience per month increase.
So we now reach our fourth and final question
and that is are the efficacy and safety data adequate
to support approval of TTS?
No.
I want to thank the committee for their hard work
and also our participants in the open public forum.
This now concludes our Advisoy Committee Meeting.
Thank you.
Don't you think there's a need for a product like this
even though this one didn't measure up?
No.
I don't feel that there's a disease.
That is a point that I'm not sure is widely shared.
If one episode a month makes people happy,
then I can help people get one episode a month.
I mean, it's a homework assignment when you come to see me.
Here we go.
It's up next.
...A testosterone patch designed to help women.
Its maker: Procter and Gamble.
It could be a huge money-maker for them
but an FDA Advisoy Panel today had some other ideas.
This is not a drug like Viagra where you take the pill
and 24 hours later it's out of your system.
Sex is a vey important part of our lives and to do without it
is something that we think we can resolve
through pharmaceutical agents today.
Amazing.
What a come back.
After failing to receive FDA approval in the United States,
Intrinsa wins authorization in the European Union
for use in women who have had radical hysterectomies
and are taking replacement estrogen.
Sex sells and so that's where you follow the money.
Follow the money.
Yeah.
Down there.
This drug will probably fail because it's not effective enough
and not safe enough to be unleashed on the world.
I'm normal, I'm normal.
That word.
Yeah.
I'm not diseased.
I'm iust normal, honey.
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